CClinicalTrials.gg
RecruitingNCT07400692Updated Sep 9, 2026

This is a Study to Find Out Whether Surgery Using a Metal Plate to Fix a Broken Elbow in Older Adults Leads to Better Recovery and Arm Function Compared to Non-surgical Treatment

An interventional study of Open reduction and plate osteosynthesis and Conservative treatment with early mobilisation in Olecranon Fracture, sponsored by Ente Ospedaliero Cantonale, Bellinzona. Recruiting at 1 site in Switzerland. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Ente Ospedaliero Cantonale, Bellinzona · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2026; still recruiting 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study summary

This study takes place in one hospital and uses a random method to divide patients into groups. It looks at the best way to treat a broken elbow (specifically, a displaced olecranon fracture) in older adults who don't use their arms heavily. There are 84 patients in total, with 42 people in each group

02

Conditions studied

  • Olecranon Fracture
03

In context

Lead sponsor

Ente Ospedaliero Cantonale, Bellinzona is the lead sponsor of 37 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with an acute (\< 2 weeks) Mayo type 2A or 2B olecranon fracture
  • Patients aged > 65 years • Patients with reduced functional demand, with a score > 2 and \< 7 on the Clinical Frailty Scale
  • Patients able to provide informed consent and follow all study procedures as indicated in the protocol
  • Signed informed consent for study participation

Exclusion criteria

Exclusion criteria:

  • Patients aged \< 65 years or with a Clinical Frailty Scale score > 7 or \< 2
  • Patients with a Mayo type 2A or 2B fracture seen more than 2 weeks after injury
  • Old fracture (> 6 months), pseudoarthrosis, or unhealed nerve injury of the ipsilateral upper limb
  • Open (Gustilo-Anderson type 2 or 3) or pathological fracture
  • Previous injury to, or other condition of, the elbow with severe functional impairment
  • Patients with severe comorbidities preventing safe surgical treatment
  • Other acute fracture or nerve damage of the ipsilateral upper limb
  • Known drug or alcohol abuse
  • Inability to follow study procedures (e.g., due to language barriers or severe comorbidities)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
84 participants (estimated)

Study arms

  • Experimental
    surgery

    Open reduction and plate osteosynthesis. The surgical treatment will be performed with a direct approach to the olecranon using a locking compression plate.

    Procedure: Open reduction and plate osteosynthesis

  • Other
    rehabilitation

    Standard rehabilitation with optional upper arm sling for comfort for 2 weeks and progressive mobilization protocol

    Other: Conservative treatment with early mobilisation

Interventions

  • ProcedureOpen reduction and plate osteosynthesis

    A cut is made along the back of the elbow to reach the broken bone. The surgeon carefully moves tissues aside and protects nearby nerves. The broken bone is cleaned, realigned, and held in place with a special metal plate and screws. This helps support the bone, especially in older patients with fragile bones. The surgeon checks the placement using live X-ray and moves the arm to ensure stability. The area is then closed with stitches, bandaged, and sometimes supported with a light splint. Recovery starts early, with gentle exercises to regain movement while protecting the repair.

  • OtherConservative treatment with early mobilisation

    Conservativel treatment usually involves wearing a sling or light support for about two weeks to manage pain. After that, the patient begins gentle, supervised arm movements to prevent stiffness and muscle loss. As the pain improves, exercises become more active and focused on regaining strength. The goal is to let the bone heal while keeping the elbow working well.

06

What researchers measure

Primary outcomes

  1. between-group difference in the Oxford Elbow Score (Italian Version) with the subscales Function, Pain, and Social-Psychological

    the Oxford Elbow Score is a patient-reported outcome measure specifically developed to evaluate elbow function. It includes 12 items divided into three domains: elbow pain, elbow function, and social-psychological impact. Each item is scored on a 5-point scale, and domain scores can be summed to obtain an overall score, where higher values indicate better outcomes. It is validated for use in both clinical and research settings and is sensitive to change, making it suitable for assessing treatment effects in patients with elbow disorders

    Time frame: 6 months after injury

07

Study locations

1 of 1 sites recruiting
  • EOC - Orthopaedics and Traumatology Service
    Lugano, 6900, Switzerland
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07400692
Lead sponsor
Ente Ospedaliero Cantonale, Bellinzona
Responsible party
Sponsor
First posted
Feb 10, 2026
Start date
Feb 3, 2026
Primary completion
Feb 3, 2030 (estimated)
Completion
Feb 3, 2030 (estimated)
Last update
Sep 9, 2026

Study contacts

Davide Previtali, MD
Contact
RicercaOrtopedia.ORL@eoc.ch
0041918117029
Davide Previtali, MD
principal investigator · EOC

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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